Novartis, Sanofi unveil data backing their rival MS pills

Novartis is touting a new data analysis suggesting that early treatment with its multiple sclerosis drug Gilenya can ward off relapses--and even prevent the loss of brain volume that often plagues MS patients. It's just one of the studies Novartis ($NVS) hopes will support increased use of its MS pill, the first oral therapy for the disease when it was launched last year.

And as new oral MS drugs make their debut, Novartis will need ways to sharpen Gilenya's competitive edge. Sanofi's ($SNY) Aubagio has hit the market, and Biogen Idec's ($BIIB) BG-12 is widely hailed as a major contender. In fact, Sanofi's Genzyme unit has also unveiled new research, showing Aubagio cut the rate of relapses and slowed progression of disability.

Presented at the European Committee for Treatment and Research in Multiple Sclerosis, the Novartis analysis showed that, in one study, Gilenya patients had a 35% reduction in loss of brain volume compared with placebo. In another, the reduction in volume loss was 39%. Both results were based on MRI scans taken after 6 months of therapy.

And in a boost for Gilenya's safety rep, new data revealed no additional red flags. The drug's safety profile in a 3,500-patient study has so far been "generally consistent with previous results," the company said. Meanwhile, other data showed that Gilenya patients continued their drug therapy as directed more often than patients treated with injectable drugs. As PM Live notes, Gilenya recently got new labeling that highlights its risks to patients with a history of heart disease or stroke.

Meanwhile, Genzyme announced that higher-dose Aubagio not only cut the rate of relapses by 36.6%, when compared with placebo, but the proportion of patients who were relapse free was "significantly higher" in the Aubagio group. Of the Aubagio patients 52% were relapse-free, compared with 38% of placebo patients. In the lower-dose Aubagio group, the reduction in relapse rate was 22.3%.

- get the Novartis announcement
- read the Genzyme release
- see the PM Live piece
- here's more from FierceBiotech

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